Feeding Malnourished Children Different Types of Fatty Acids to Promote Neurocognitive Development
Improved Polyunsaturated Ready-to-use Therapeutic Food for Improved Neurocognitive Outcomes in Severe Acute Malnutrition
1 other identifier
interventional
2,897
1 country
1
Brief Summary
An appropriate balance of omega-6 and omega-3 fatty acids is important for support of neurocognitive development in healthy infants and toddlers. In young children recovering from severe acute malnutrition (SAM), excess omega-6 intake depletes omega-3 fatty acid status. This research will evaluate how novel ready-to-use therapeutic foods (RUTF) with balanced fatty acids improve the metabolic and neurocognitive effects in young children in Malawi recovering from SAM, yielding new knowledge that also has implications for development of well-nourished children.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2017
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 23, 2017
CompletedFirst Posted
Study publicly available on registry
March 29, 2017
CompletedStudy Start
First participant enrolled
October 2, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 23, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 23, 2021
CompletedJuly 19, 2022
July 1, 2022
3.5 years
March 23, 2017
July 14, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Neurocognitive outcome
Measured by score on the Malawian Developmental Assessment Test (MDAT). The scale is continuous and interval in nature, the range varies by population * The scale title is "Malawi Developmental Assessment Tool z-score" * The primary outcome is Global z-score, titled "Global z-sore" * Secondary outcomes are 4 sub-domain z-scores are titled "Gross motor z-score", "Fine motor z-score", Language z-score", and "Social z-score"
Time Frame: 4 to 7 months after nutritional outcome
Neurocognitive outcome
Defined by Willatts intention score adapted for field training, 3 problems to be tested. The scale is ordinal in nature, with higher values indicated better scores * The scale title is "Intention Score" * Problem 1 is scored 0 - 4 * Problem 2 is scored 0 - 4 * Problem 3 is scored 0 - 8
Time Frame: within 4 weeks after nutritional outcome
Secondary Outcomes (4)
Nutritional recovery
Up to 12 weeks following enrollment
Attentional orienting speed
4-7 months after nutritional after nutritional outcome
Adverse Events
Fortnightly follow up visits up to 12 weeks following enrollment
Acceptance of RUTF
Fortnightly follow up visits up to 12 weeks following enrollment
Study Arms (3)
Conventional RUTF (S-RUTF)
ACTIVE COMPARATORThis is the control group for the study, which will receive the international standard of care therapeutic food. S-RUTF is made with conventional peanuts, which are inherently high in omega-6 linoleic acid.
High oleic RUTF (HO-RUTF)
EXPERIMENTALThe treatment provided to children randomized to this arm of the study includes nutritional content comparable to S-RUTF with the exception of a low lineoleic acid/high oleic acid ratio formulated with high oleic content peanuts.
DHA-supplemented HO-RUTF (D-HO-RUTF)
EXPERIMENTALThe treatment provided to children randomized to this arm of the study mirrors that provided by HO-RUTF with that addition of supplemental DHA at a level higher than attainable with optimal precursors.
Interventions
All patients with severe acute malnutrition will receive a course of amoxicillin.
HO-RUTF: Milk, perilla oil, palm oil, white sugar, high oleic peanuts
D-HO-RUTF: DHA, milk, perilla oil, palm oil, white sugar, high oleic peanuts
S-RUTF: Milk, canola oil, palm oil, white sugar, standard peanuts
Eligibility Criteria
You may qualify if:
- months
- An acceptable appetite defined by the ability to consume 30 grams RUTF within 20 minutes
- Mid Upper Arm Circumference \<11.5 cm, weight-for-height z-score \< -3, or bilateral pitting edema on the dorsum of the feet
You may not qualify if:
- Participation in any other ongoing study or supplementary feeding program
- Children with a chronic medical condition, including cerebral palsy, static encephalopathy, congenital heart disease, gastrointestinal disease, or peanut allergy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Washington University School of Medicinelead
- University of Texas at Austincollaborator
- Cornell Universitycollaborator
- Kamuzu University of Health Sciencescollaborator
Study Sites (1)
University of Malawi College of Medicine
Blantyre, Malawi
Related Publications (1)
Stephenson K, Callaghan-Gillespie M, Maleta K, Nkhoma M, George M, Park HG, Lee R, Humphries-Cuff I, Lacombe RJS, Wegner DR, Canfield RL, Brenna JT, Manary MJ. Low linoleic acid foods with added DHA given to Malawian children with severe acute malnutrition improve cognition: a randomized, triple-blinded, controlled clinical trial. Am J Clin Nutr. 2022 May 1;115(5):1322-1333. doi: 10.1093/ajcn/nqab363.
PMID: 34726694DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Mark J Manary, MD
Washington University School of Medicine
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 23, 2017
First Posted
March 29, 2017
Study Start
October 2, 2017
Primary Completion
March 23, 2021
Study Completion
March 23, 2021
Last Updated
July 19, 2022
Record last verified: 2022-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- Data will be available within 9 months of article publication. Data will remain available indefinitely.
- Access Criteria
- Anyone who wishes to access the data.
Individual participant data that underlie the results reported in the article after deidentification will be indefinitely available within 9 months following article publication through The Washington University Open Scholarship Institutional Repository.